COPD
Conditions
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis
Brief summary
This is an investigator-sponsored research study to evaluate if treatment with HFA-134a beclomethasone (QVAR) has an effect on peripheral (or outer) airway inflammation and airway remodeling or scarring in subjects with COPD. Approximately 20 subjects with COPD will participate for approximately 7 weeks, with 10 receiving an active (BDP) inhaler with HFA-134a and 10 receiving a placebo.
Interventions
DRUGHFA-134A Beclomethasone DIpropionate (QVAR)
Sponsors
National Jewish Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COPD diagnosis * FEV1/FVC\<70% * FEV1 50-80% predicted * Albuterol response of \<12% and \<200mL or methacholine PC20 \> 8mg/mL * RV \> 120% predicted * DLCO \< 80% * smokers and nonsmokers * Lower age limit 45 years
Exclusion criteria
* Asthma * Other chronic airway or parenchymal lung disease * Other comorbid illness (including but not limited to DM, MI or CAD-related intervention in 6 months, neurologic disease, syncope) * Use of any steroid (oral, IV, nasal, pulmonary) within 12 weeks * Use of theophylline, leukotriene modifiers within 12 weeks * Use of long-acting beta-agonists (formoterol, salmeterol) or anticholinergic (tiotropium)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spirometric response (FEV1) | — |
| Lung volumes such as residual volume (RV), thoracic gas volume, total lung capacity (TLC) and the RV/TLC ratio | — |
Countries
United States
Outcome results
None listed